Treatment and placement device for sinusitis applications

ABSTRACT

Devices, methods and kits which, when installed or used, access, aspire, dilate, insufflate, drain or deliver fluid medicaments to, or place a patency device within a sinus area, such as a maxillary sinus or a maxillary sinus ostium. The device can include a hollow catheter and probe, and can be configured to permit gradual and incremental probe extension. The device can be constructed to enhance the precision and maneuverability within the nasal and sinus passageways, while also accommodating the natural anatomical geometry of a targeted paranasal treatment site. For example, the present treatment and placement device can accomplish access to the maxillary sinus ostium by utilizing an uncinate process to guide a probe tip into the ostium in a retrograde manner. The probe can be slidably, bi-directionally or co-axially positioned within the catheter. A distal portion of the probe can be biased away from a longitudinal axis of the catheter.

CLAIM OF PRIORITY

This application is a divisional application of U.S. patent applicationSer. No. 12/837,256, filed Jul. 15, 2010, which is a non-provisionalpatent application claims the benefit of priority under 35 U.S.C.§119(e) to U.S. Provisional Patent Application Ser. No. 61/225,632,entitled “DEVICE FOR MAXILLARY SINUS OSTIUM,” (Attorney Docket No.600.794PRV), filed on Jul. 15, 2009, which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

This patent document pertains generally to devices, methods and kits totreat sinusitis. More particularly, but not by way of limitation, thispatent document pertains to treatment and placement devices, methods andkits which, when installed or used, dilate, maintain or otherwise treatsinus ostia.

BACKGROUND

“Sinusitis” refers to inflammation of one or more nasal sinus cavities,which are moist, hollow spaces in the bones of the skull. Sinusitisaffects millions of people each year. According to the NationalAmbulatory Medical Care Survey (NAMCS), approximately 14% of adultsreport having at least one yearly episode of sinusitis. Further,sinusitis is believed to be one of the top five most common diagnosesfor which antibiotics are prescribed.

There are four pairs of sinuses: frontal, maxillary, ethmoid, andsphenoid. The sinuses are located behind the eyebrows, cheekbones, andnose. The sinuses help moisten and warm air that is filtered by thenose, serving to protect the lungs. The sinus cavities, nose, and lungsare lined with mucous membranes, which protect the airways by trappingirritants that are inhaled. Tiny hair-like filaments called cilia are inconstant movement and sweep mucus and the trapped irritants out of theairways and nasal passages. In each of the sinuses, the mucus drains outof a tiny opening called the ostium.

The ostium of any sinus cavity can get plugged. When this blockageprevents the flow of mucus, the pressure builds up, leading to sinusitistypified by inflammation and pain. If the blocked sinus becomes infectedwith bacteria, the sinus becomes even more inflamed and painful.Symptoms of sinusitis can include, among other things, facial pain orpressure, discolored mucus, a diminished sense of smell, cough,headache, bad breath, fever, toothache, pressure in the ears andfatigue.

OVERVIEW

The present inventors have recognized, among other things, a need forsinus specific treatment devices that can effectuate clinical-basedtherapy, and can comfortably accommodate the natural nasal and sinusgeometries in maneuvering and placement of sinus ostium patency devices.

The present treatment and placement device is configured to access,aspire, dilate, insufflate, drain or deliver fluid medicaments to, orplace a patency device within a sinus area, such as a maxillary sinusarea, via an associated sinus ostium. The present inventors havediscovered that a device can be constructed, which enhances theprecision and maneuverability within the nasal and sinus passageways,while also accommodating the natural anatomical geometry of a targettreatment site, such as the maxillary sinus. Although accessing themaxillary sinus can be achieved through a nostril and associated nasalcavity, such an approach is complicated by an intermediate or middleconcha that projects over the maxillary sinus ostium, as well as, anuncinate process that obstructs the approach in an anterior towardposterior direction. The present treatment and placement deviceaccomplishes access to the maxillary sinus ostium, for example, byutilizing the uncinate process to guide a moveable probe tip into theostium in a retrograde, posterior toward anterior manner.

To better illustrate the devices, methods and kits disclosed herein, anon-limiting list of examples is provided here:

In Example 1, a device for accessing a sinus ostium comprises a catheterextending from a proximal end to a distal end, and including alongitudinally-extending lumen and an intersecting side portal; and aprobe at least partially nested within the longitudinally-extendinglumen, a portion of the probe movable within the lumen such that a probetip is advanceable out of the intersecting side portal, wherein theintersecting side portal is located proximal to the distal end of thecatheter.

In Example 2, the device of Example 1 is optionally configured such thatthe probe includes a first portion and a second portion separated by apreformed bend, the first portion extending from a probe proximal end tothe preformed bend and the second portion extending from the preformedbend in a direction toward the probe proximal end.

In Example 3, the device of any one or any combination of Examples 1 and2 is optionally configured such that the preformed bend forms an anglebetween about 90 degrees and about 180 degrees relative to an axisdefined by the catheter distal end.

In Example 4, the device of Example 2 is optionally configured such thatthe probe tip advances out of the intersecting side portal at an angleless than 90 degrees relative to an axis defined by the first portion ofthe probe at a superimposed position of the probe tip. In some examples,the advancing angle is between about 15 degrees and about 75 degrees,and more preferably, between about 20 degrees and about 60 degrees.

In Example 5, the device of any one or any combination of Examples 1-4is optionally configured such that the probe tip is configured toadvance out of the intersecting side portal in a posterior to anteriordirection.

In Example 6, the device of any one or any combination of Examples 1-5is optionally configured such that a distal portion of the catheterincludes an arcuate shape and a groove, located proximal to theintersecting side portal, to assist probe tip advancement and support.

In Example 7, the device of any one or any combination of Examples 1-6is optionally configured such that the probe is moveable within thelongitudinally-extending lumen without movement of the catheter.

In Example 8, the device of any one or any combination of Examples 1-7is optionally configured such that the probe includes a tubularconfiguration and one or more openings at or near the probe tip.

In Example 9, the device of Example 8 optionally further comprises aninflatable or expansible element coupled to the probe at or near theprobe tip, such that the one or more openings are in communication withan interior of the inflatable or expansible element.

In Example 10, the device of any one or any combination of Examples 1-9is optionally configured such that the catheter includes a combinationof a semi-rigid internal material and a softer, more pliable exteriormaterial.

In Example 11, a method comprises advancing a catheter and a probe, theprobe including a double-backed portion nested inside the catheter,within a middle meatus between an intermediate concha and an inferiorconcha; and accessing a maxillary sinus ostium using the double-backedportion of the probe, including actuating a probe tip in a postier toanterior direction.

In Example 12, the method of Example 11 is optionally configured suchthat actuating the probe tip and accessing the maxillary sinus ostiumincludes using an uncinate process to aid in guiding the probe tip intothe maxillary sinus ostium.

In Example 13, the method of any one or any combination of Examples 11or 12 is optionally configured such that actuating the probe tipincludes linearly moving an actuation mechanism, coupled to the probe,in a proximal direction.

In Example 14, the method of any one or any combination of Examples11-13 is optionally configured such that actuating the probe tipincludes moving the catheter in an anterior to postier direction.

In Example 15, the method of any one or any combination of Examples11-14 is optionally configured such that actuating the probe tipincludes allowing a preformed probe tip to bias away from a longitudinalaxis of the catheter.

In Example 16, the method of any one or any combination of Examples11-15 is optionally configured such that advancing the catheter andprobe, the probe nested inside the catheter, includes advancing a sinusostium patency device removably coupled to a portion of the catheter orprobe.

In Example 17, the method of any one or any combination of Examples11-16 optionally further comprises performing one or more of: aspiring,dilating, insufflating, draining, delivering fluid medicaments to, orplacing a patency device within the maxillary sinus ostium or maxillarysinus cavity.

In Example 18, the method of Example 17 is optionally configured suchthat aspiring, dilating, insufflating, draining or delivering fluidmedicaments to the maxillary sinus ostium or maxillary sinus cavityincludes using one or more openings at or near the probe tip and a fluidcontainer in communication with a probe proximal end.

In Example 19, the method of Example 17 is optionally configured suchthat dilating the maxillary sinus ostium includes inflating a ballooncoupled to the probe at or near the probe tip.

In Example 20, the method of Example 19 optionally further comprisesplacing the patency device within the dilated maxillary sinus ostium.

In Example 21, the method of any one or any combination of Examples11-20 is optionally configured such that accessing the maxillary sinusostium using the probe includes using tactile feedback.

In Example 22, a kit comprises a device according to any one or anycombination of Examples 1-10; and a set of instructions for using thedevice to treat an ostium associated with a maxillary sinus.

In Example 23, the kit of Example 22 optionally further comprises asinus ostium patency device, the patency device including a partiallyopen cross-sectional configuration for maintaining a track of uncoveredcilia within the ostium.

In Example 24, the device, method or kit of any one or any combinationof Examples 1-23 is optionally configured such that all elements oroptions recited are available to use or select from.

These and other examples, advantages, and features of the presenttreatment and placement devices, methods and kits will be set forth inpart in following Detailed Description. This Overview is intended toprovide non-limiting examples of the present subject matter—it is notintended to provide an exclusive or exhaustive explanation. The DetailedDescription is included to provide further information about the presenttreatment and placement devices, methods and kits.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like numerals can be used to describe similarcomponents throughout the several views. Like numerals having differentletter suffixes can be used to represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1 illustrates an example schematic view of anatomical tissuestructures including the maxillary, frontal, and ethmoid sinus cavities,such tissue structures providing a suitable environment in which atreatment and placement device, as constructed in accordance with atleast one embodiment, can be used.

FIG. 2A-2B illustrate schematic and detailed views of an exampletreatment and placement device, as constructed in accordance with atleast one embodiment.

FIGS. 3A-3B illustrate schematic and detailed views of an exampletreatment and placement device and a patency device positioned within asinus ostium, the treatment and placement device and the patency deviceas constructed in accordance with at least one embodiment.

FIGS. 4A-4B illustrate side views of a distal portion of an exampletreatment and placement device, including the interplay between a hollowcatheter and a nested probe, as constructed in accordance with at leastone embodiment.

FIGS. 5A-5B illustrate side views of a distal portion of an exampletreatment and placement device, as viewed along a plane parallel to aflat device portion and toward the generally flat portion, asconstructed in accordance with at least one embodiment.

FIG. 6 illustrates a side, cross-sectional view of an example treatmentand placement device, as constructed in accordance with at least oneembodiment.

FIG. 7 illustrates an end view of a distal portion of an exampletreatment and placement device, as constructed in accordance with atleast one embodiment.

FIGS. 8A-8D illustrates an example experimental prototype of a presenttreatment and placement device.

DETAILED DESCRIPTION

The present invention provides devices, methods and kits for accessingand treating a maxillary sinus ostium and associated maxillary sinus,for example. The device is structured to accommodate natural sinusgeometry, including the maxillary sinus and maxillary sinus ostium, interms of its dimensions, configurations, or operability. In variousexamples, a distal curvature of the device can be configured forinsertion and positioning the distal portion of the device adjacent tothe maxillary sinus ostium and within the middle meatus between theintermediate concha and inferior concha. Features of the present deviceincrease the precision of positioning into the maxillary sinus ostium byaccounting for the complications associated with the intermediateconcha, which projects over the maxillary sinus ostium, and the uncinateprocess which obstructs the approach in an anterior toward posteriordirection. The distal portion of the device can utilize the uncinateprocess to guide a probe tip into the maxillary sinus ostium. These andother components of the device can be configured to perform a variety offunctions within the maxillary sinus ostium or the maxillary sinuscavity, including but not limited to, dilation, insufflation, fluid ormedication delivery, drainage, sinus ostium patency device delivery,biopsy and sampling, cutting or ablation, or endoscopic visualization.

To facilitate understanding of the physiology associated with thepresent treatment and placement devices, methods and kits, FIG. 1illustrates anatomical tissue structures 100 associated with sinusitis.There are four different pairs of sinuses—the frontal sinuses 102, theethmoid sinuses 104, the maxillary sinuses 106, and the sphenoid sinuses(located more toward the back of the head than the other sinuses).Normally, sinuses are filled with air, but when sinuses become blockedand filled with fluid, pathogens can grow and cause an infection. InFIG. 1, the sinuses on the (reader's) right side are shown as inflamed,infected and experiencing sinusitis 108.

Sinusitis 108 can be acute or chronic. Acute sinusitis usually lasts forapproximately 3 weeks, but can persist for as long as 3 months. Acutesinusitis is usually caused by a viral respiratory infection. Subjectswith acute or recurrent acute sinusitis are typically treated withantibiotics or over-the-counter decongestants.

Chronic sinusitis lasts longer than three months and does not respondwell to conventional antibiotic treatment. Chronic sinusitis can also becaused by infection, but is more often caused by inflammation andblockage due to allergies or a physical obstruction (e.g., collapsedbone or cartilage structures or foreign objects). Traditionally, chronicsinusitis is treated using Functional Endoscopic Sinus Surgery, commonlyknown as a FESS procedure. During a traditional FESS procedure, aphysician caregiver resects or removes bone and tissue to enlarge asinus ostium of interest to restore adequate cavity drainage. Removal ofbone and tissue can lead to considerable post-operative pain.

A technological concept of the present treatment and placement devices,methods and kits is to open and maintain a blocked maxillary sinusostium 110 extending between a cavity of the maxillary sinus 106 and anasal passage 112, for example, to reduce mucus pressure build-up andthe resulting pain experience by a subject without removing bone ortissue. Non-removal procedures, by nature, are associated with lesshealing times and discomfort than invasive removal procedures, and thus,provide advantages over surgical such procedures.

FIGS. 2A and 2B illustrate schematic and detailed views of an exampletreatment and placement device 200. The treatment and placement device200 can extend from a first, proximal portion 202 to a second, distalportion 204, and can include a catheter 206 that houses a movable probe208 (shown in a deployed position). The probe 208 can be doubled-backedwithin the catheter 206 so that its tip 210 faces towards the firstportion 202 of the device 200. The probe tip 210 can be enabled throughthe use of a side or lateral portal 212 in the catheter 206, in lieu ofa distal tip 214 portal, and can be configured for delivery of a therapyor a patency implant, or dilation (e.g., via a balloon), among otherthings. The catheter 206 can have a longitudinal axis 216 and aninternal lumen 218. The side or lateral portal 212 can be incommunication with the internal lumen 218 and located proximal thedistal tip 214 of the catheter 206. In various examples, the secondportion 204 of the catheter can include a generally arcuateconfiguration, as shown in the reoriented illustration of FIG. 2B, tofacilitate positioning adjacent to the maxillary sinus ostium 110(FIG. 1) and within the middle meatus between the intermediate conchaand inferior concha.

The probe 208 can be actuated for retrograde movement (i.e., movementtoward the first portion 202) without requiring movement of the catheter206. The movement of the probe 208 relative to the catheter 206 isshown, for example, in FIGS. 4A (nested position) and 4B (deployedposition). Advantageously, the probe's 208 ability to be actuated andextend away from the stationary catheter 206 can reduce the need for“poking” to locate an ostium and can increase the precision of ostiumaccess.

A variety of mechanisms can be used to move the probe 208 relative tothe catheter 206. As shown in the example of FIG. 2A, the treatment andplacement device 200 can include a handle assembly 220 at the firstportion 202. The handle assembly 220 can include a handle housing and amanually controllable sliding switch 222. The sliding switch 222 can bemechanically coupled to a proximal end 224 of the probe 208, and aproximal end 226 of the catheter 206 can be fixedly attached to a distalend 228 of the handle assembly 220. In this example, movement of thesliding switch 222 in the proximal direction can correspondingly move adistal tip 210 portion of the probe 208 in the proximal direction.Advantageously, linear movement of the sliding switch 222 or othermechanical mechanism, in combination with a biased outward orientationof the double-packed portion 606 (FIG. 6) of the probe 208, can allowgradual and incremental spacing between the deployed probe portion andthe catheter 206 (e.g., when moved proximally, the double-backed portionof the probe 208 is permitted to incrementally extend away from thecatheter 206), thereby allowing for precise ostium 110 delivery of atherapy (e.g., medicament), dilation or delivery of an ostium patencyimplant, among other things. Alternatively, the probe 208 can bedeployed by moving the catheter 208 in the distal direction therebypermitting extension of the probe 208 with the linear portion of theprobe being stationary relative to sinus position.

The probe 208, catheter 206, or both, can be constructed to perform avariety of functions in addition delivery of a therapy, dilation ordelivery of a patency implant. The one or more portions of the probe 208can be in the form of a solid stylet or access instrument. The probe 208can be structured for positioning and depositing of a variety ofimplantable devices into the maxillary sinus ostium 110. The probe 208can be configured as a hollow tube, and can comprise one or more portsor openings at or near the distal tip 210 for insufflation, infusion orfluid delivery to the ostium 110 or directly into the maxillary sinus106 (FIG. 1). A variety of fluid medicaments can be applied to a subjectpatient using the treatment and placement device 200. The distal tip 210portion of the probe 208 can include an inflatable or expansibleelement, such as a stent or balloon structure. In some examples, thedistal tip 210 portion of the probe 208 can include ultrasonic orelectrical components for ablation or cauterization. Additionalequipment and components, such as endoscopic visualization equipment orillumination systems, can also be incorporated into the handle assembly220 or elsewhere.

The catheter 206 can be composed of a semi-rigid, flexible materialhaving structural integrity sufficient to permit positioning within asinus and maneuvering and operation of the device 200, while permittingyielding and bending in response to encountered anatomical barriers andobstacles within the nasal and sinus passageways. Suitable materialsinclude, but are not limited to, plastics and polymeric materials.Examples of suitable plastics and polymeric materials include, but arenot limited to, silastic materials and silicon-based polymers,polyurethane, and the like. In some examples, soft durometer materialsare used for the catheter 206 to reduce subject recipient discomfort. Insome examples, the catheter 206 can be composed of two differentmaterials, such as the combination of a semi-rigid internal material anda soft, pliable exterior material.

The probe 208 can be composed of semi-rigid, flexible material havingsufficient structural integrity to permit operation within the device200 and insertion into a maxillary sinus ostium 110, for example.Suitable materials include, but are not limited to, plastics andpolymeric materials, and metals and metallic alloys. Examples of metalsand alloys that can be employed include, but are not limited to,Nitinol, titanium, stainless steel, and the like.

Any part of the treatment and placement device 200 can include aradiopaque marker as either a solid marker attached to a portion of thedevice or as fine powder mixed with the catheter or probe materialduring construction. Additional features for the treatment and placementdevice 200 include: pre-loading of a diagnostic, therapeutic or otheractive agent; a reservoir (e.g., to store active agent(s)); inclusion ofan endoscope of other internal viewing device (e.g., a light-emittingmeans); coating with a hydrophilic material; configuration for placementwithin a frontal sinus; a hose for draining and/or rinsing a maxillarysinus; or specimen capturing jaws for removal of a tissue sample(biopsy).

As shown in FIGS. 3A and 3B, a treatment and placement device 200 can bedesigned to navigate the bony and cartilaginous obstructions within anasal passageway 112 and access a maxillary sinus ostium 110 fordilation, insufflation, fluid or medication delivery, drainage, sinusostium patency device delivery, biopsy and sampling, cutting or ablationor endoscopic visualization, among other things, in a retrograde manner.This novel approach is unique and can be enabled through the use of aside or lateral portal instead of a distal portal. Specifically, FIGS.3A and 3B illustrate a catheter 206 positioned inside the nasalpassageway 112 and a probe 208 in a deployed position, partiallyinserted into the maxillary sinus ostium 110.

The overall catheter 206, or portions thereof, can be shaped tofacilitate positioning alongside the sinus ostium 110 by providing anangle configured to enter the nasal passageway 112 and slide within themiddle meatus between a middle concha 304 and an inferior concha 302.The probe 208 that exits the catheter 206 via the lateral portal 212 canbe shaped so that it bends toward the sinus ostium 110 and uses anuncinate process 306 to aid in advancement into the ostium 110. Locationmonitoring of the catheter 206 and probe 208 during a procedure can, insome examples, be determined using tactile feedback alone or incombination with an imaging means.

The probe 208 can be separately actuated for retrograde movement withoutrequiring movement of the catheter 206. The first portion 202 of thetreatment and placement device 200 can include a handle assembly 220with a sliding switch or other mechanism 222 to actuate the probe 208out of, and back into, the catheter 206. A balloon or other dilator 308can be advanced via actuation of the probe 208 and positioned through ablocked sinus ostium 110. When the balloon or other dilator 308 isinflated (e.g., via a lumen within the probe 208), the fragile bones ofthe sinus ostium 110 can be permanently or sufficiently moved aside toopen up air and mucus flow. Optionally, a sinus ostium patency device310 can then be advanced via actuation of the probe 208 and insertedinto a newly-unblocked sinus ostium 110. Additionally, a lumen withinthe probe 208 can be used to deliver therapeutic pharmaceutical agents,irrigation fluid, or other therapies directly into the maxillary sinus106 (FIG. 1). The lumen can also house an actuation wire or electricalwires that can be used to power a therapy. Additional device controlscan exist, such as fluidic port(s) 312 in the handle assembly 220 canprovide attachment to pressure or fluid delivery applications.

A retail kit may also be packaged for consumer purchase. The kit caninclude one or both of a treatment and placement device 200 and a sinusostium patency device 310, such as that described in commonly-ownedArcand, et al., U.S. patent application Ser. No. ______, entitled“IMPLANTABLE DEVICES FOR TREATMENT OF SINUSITIS,” filed concurrentlyherewith, the entire text of which is incorporated herein by reference.The kit can also include a set of instructions for using the treatmentand placement device or the patency device. In some examples, the kitincludes one or more separate tools for withdrawing the sinus ostiumpatency device from an implanted position.

In operation, the second, distal portion 204 of the treatment andplacement device 200 is inserted into position within the maxillarysinus 106 adjacent to the maxillary sinus ostium 110. Once the catheter206 has been positioned, movement of the probe 208 in the proximaldirection progressively or incrementally releases the probe's 208preconfigured bias from within the catheter (see, e.g., FIG. 6). As theproximal movement of the probe 208 continues, the probe tip 210gradually extends outward away from a longitudinal axis 216 of thecatheter 206, as shown in FIG. 4B. By retrograde movement of the freetip 210 of the probe 208 alone or in simultaneous retrograde movement ofthe probe 208 and catheter 206 together, the probe tip 210 can beinserted into the maxillary sinus ostium 110.

As shown in FIGS. 4A and 4B, the treatment and placement device 200 cancomprise a portal 212 on a medial lateral surface portion of thecatheter 206, in communication with a catheter lumen 218, and locatedproximal to a catheter distal end 214. In the example shown, the portal212 is illustrated as an elongated channel or trough located in thecatheter body through which the probe 208 can reside when deployed.Although illustrated as an elongated channel, the portal 212 can have avariety of shapes or configurations. For example, the portal 212 can beoval, or configured as a side portal through which a double-backedportion of the probe 208 can exit. An advantage associated with theelongated channel or trough portal 212 is that an arcuate configurationof the double-backed portion of the probe 208 can reside within thechannel and cooperate with a generally arcuate distal catheter 206configuration. In this way, the double-backed portion of the probe 208can likewise have a generally arcuate configuration that can bemaintained throughout the gradual outward biased extension affected bythe deployment of the probe 208 from the catheter 206.

FIG. 5A is a side view of a second, distal portion 204 of an exampletreatment and placement device. In this example, a probe 208 is shown ina deployed position, as viewed along a plane 506 parallel to opposingflat sides 502, 504 of the device. FIG. 5B is also a side view of thesecond, distal portion 204 of the treatment and placement device. Inthis example, the probe 208 is shown in the deployed position, as viewedtoward a flat side 502 of the device.

In various examples, a distal tip 214 of the catheter 206 is rounded andsmooth to increase comfort and reduce trauma during device 200positioning within a subject recipient. In some examples, a distalportion 204 of the device includes an elliptical, rectangular or ovoidflattened cross-section. In the example of FIGS. 5A and 5B, the distalportion 204 includes two opposing sides 502, 504 having generally flatsurfaces.

The double-backed portion of the probe 208 can have a preformed arcuateconfiguration consistent with an arcuate configuration of the catheter206. The double-backed portion of the probe 208 can be biased at a bend602 (see, e.g., FIG. 6) to extend a probe tip 210 away from alongitudinal axis 216 of the catheter 206 at an angle 604 (FIG. 6) ofabout 90 degrees or less relative to a proximal portion of the axis 216.The angle 604 can be measured using the probe tip 210 relative to thevertex of the bend 602 and the general longitudinal axis 216 runningbetween a proximal end of the catheter 206 and the bend 602. The angle604 can vary based on the particular subject recipient's anatomicalgeometry. For example, the preferred probe 208 extension angle for atypical adult can be about 95 degrees or less. The preferred probe 208extension angle for a child can be about 60 degrees or less.

FIG. 6 illustrates a cross-sectional side view of a second, distalportion 204 of an example treatment and placement device. In thisexample, a probe 208 is shown in a deployed position, as viewed towardan edge of a generally flat side 502 of the device. When the probe 208is deployed, a probe tip 210 extends away from a catheter 208, whileremaining portions of the probe 208 remain nested within a lumen of thecatheter 208. A double-backed portion 606 of the probe 208 created bythe bend 602 can form an obtuse angle 608 between about 90 degrees andabout 180 degrees relative to a distal portion of the longitudinal axis216. The double-backed portion 606 of the probe 208 can be biased, asshown, at the bend 602 to extend the probe tip 210 away from alongitudinal catheter axis 216 to an angle 604 of about 90 degrees orless relative to a proximal portion of the longitudinal axis 216.

The preformed bend 602 and preformed extension bias of the probe 208 canbe associated with operative advantages of the device. For example, thepreformed bend 602 can reduce the likelihood of kinking, buckling, orother deformation of the probe 208, relative to “pushing” approaches,due to its “pulling” or retrograde movement approach. In addition, thepreformed bend angle 604 of the probe 208 can allow for multipledirection movement using a single actuation force (e.g., proximalmovement of a sliding switch can result in proximal and outward movementof the probe tip 210). Furthermore, the retrograde probe movement madepossible by the bend 602 accounts for natural anatomical geometry toenhance positioning of the probe tip 210 into the ostium 110 (FIG. 1) ofa subject recipient.

In various examples, the cross-sectional dimension (e.g., diameter orthickness) of the probe tip 210 is configured to accommodate the naturalinterior dimensions of the maxillary sinus ostium 110 to permit entryand movement within the sinus structure. In some examples, the outerdiametrical dimension of the probe tip 210 can be about 5.0 mm or less,preferably between about 5.0 mm and about 0.5 mm, provided thestructural integrity of the probe 208 needed for a desired function isnot substantially compromised by its cross-sectional dimension.

FIG. 7 illustrates an end view of a distal portion 204 of an exampletreatment and placement device. In this example, a probe 208 is shown ina deployed position. In addition or in combination with the outward biasangle 604 (FIG. 6) relative to the longitudinal device axis 216, thebias movement of the probe 208 can be askew as opposed to a purelyperpendicular directional movement relative to the catheter 206. Usingreference plane 506 from FIGS. 5A and 5B, and a reference plane 702perpendicular to plane 506, a probe tip 210 can be shown to have anaskew outward bias deployed state which, in combination with the otherdevice features disclosed herein, can be used to accommodate the naturalgeometry of the maxillary sinus by more precisely positioning the probetip 210 in alignment with the maxillary sinus ostium.

Throughout this disclosure, the treatment and placement device 200 hasbeen described herein as a device for accessing a maxillary sinus ostiumand associated maxillary sinus. In many of these embodiments, the probe208 extends in a direction substantially parallel to a lateral planeshared with an arcuate distal portion of the device. Alternatively, theteachings of the present device can be constructed and configured foraccessing a frontal sinus and frontal sinus ostium, for example. Forfrontal sinus embodiments, the device can be constructed so that theprobe 208 extends in a lateral direction perpendicular to a plane of thearcuate distal portion of the device to orient the probe 208 in anupward direction when positioned within the frontal sinus.

In various examples, such as to accommodate subject-varying maxillarysinus ostia and frontal sinus ostia geometries, the treatment andplacement device 200 can be configured such the probe 208 can bedirectionally controlled by a physician caregiver. This directionalcontrol can include angular extension control of the probe 208 relativeto the catheter 206, side extension control of the probe 208 from thecatheter 206 (e.g., to accommodate left or right side sinus ostia) orretrograde movement control of the probe 208, among other directionaloptions physician caregivers would like to select from to achieve betterprobe tip alignment with a desired ostium. It should be understood thatthe treatment and placement device 200 configurations discussed hereincan be adjusted, as necessary, to accommodate left anatomical sinus usesin addition to right anatomical sinus uses. Illustrations in thedrawings depicting a left or right side sinus use do not imply alimitation of the invention confining the device structure andconfiguration to the one particular anatomical side.

EXPERIMENTAL EXAMPLE

In order that the present treatment and placement device can be morefully understood, the example experimental prototype of FIGS. 8A-8D isgiven by way of illustration. In this example, the treatment anddelivery device 800 includes a handle assembly 820 including a slidingswitch 822 to actuate a probe 808 nested within a catheter 806. A distalend of the catheter 806 is sized and shaped to aid in positioning thedevice 800 within a nasal passageway. The distal end of the catheter 806consists of a sleeve that is shaped with a non-circular cross-section toposition itself under a middle turbinate. The sleeve of the catheter 806houses the probe 808 used to gain access to a maxillary sinus ostium.The probe 808 exits via a portal 812, which is located near, butproximal, the distal end of the catheter 808. Additionally, a groove 850proximal to the portal 812 was built into the catheter 808 to assist aprobe tip 810 into the ostium and providing a backing to help push theprobe tip 812 into the ostium. In this example, the groove 850 in thecatheter 806 is directed such that the probe 808 exits laterally. FIGS.8A-8B, in order, show an example advancement of the probe tip 810 fromthe catheter 806.

Closing Notes:

Treatment and placement devices, methods and kits which, when installedor used, access, aspire, dilate, insufflate, drain or deliver fluidmedicaments to, or place a patency device within a sinus area, such as amaxillary sinus and a maxillary sinus ostium. A treatment and placementdevice can include a catheter that houses a probe, and optionally, asinus ostium patency device. A tip of the probe is design to exit from alateral portal in the catheter, which is located proximal to a distalend of the device, by being pulled proximally or in a retrograde manner.This can allow the catheter to position the probe tip for access to asinus ostium of interest, and easily allows the probe tip to bedelivered from a posterior to anterior direction into the ostium. Theprobe that is housed in the catheter is double-backed so that its tipfaces toward a proximal end of the device.

The overall catheter can be shaped to get the probe positioned alongsidethe ostium by providing the correct angle to enter the nostril and slidealong the underside of a middle concha. The probe that exits thecatheter can also be shaped so that it bends toward a lateral nasal wall(toward the ostium) and uses an uncinate process to aid in guiding theprobe tip into the maxillary sinus ostium, for example. Optionally, asinus ostium patency device can be attached to an end of the probe thatexits the catheter and enters the ostium. Additionally, the probe,catheter, or both, can be used to deliver therapeutic pharmaceuticals orother therapies directly into the sinus of interest. A lumen of one ofthe probe or catheter can be used to house an actuation wire orelectrical wires that can be used to power a therapy or release animplant mechanism. After delivery of the desired implants or therapy,the lumen can be retracted back into the catheter for easy removal.

Advantageously, the present treatment and placement devices, methods andkits are believed to lower the overall cost of sinus care and preventlong term health issues by, among other things, (a) reducing thedependence on systemic pharmaceuticals and other medications, (b)avoiding invasive, cutting-based procedures for patency device placementwith an ostium, (c) providing an ease of use not previously seen beforein the sinus access field, and/or (d) facilitating a blind (e.g., endoscope-less) device delivery procedure.

The above Detailed Description includes references to the accompanyingdrawings, which form a part of the Detailed Description. The drawingsshow, by way of illustration, specific embodiments in which the presenttreatment and placement devices, methods and kits can be practiced.These embodiments are also referred to herein as “examples.” Allpublications, patents, and patent documents referred to in this documentare incorporated by reference herein in their entirety, as thoughindividually incorporated by reference. In the event of inconsistentusages between this document and those documents so incorporated byreference, the usage in the incorporated reference(s) should beconsidered supplementary to that of this document; for irreconcilableinconsistencies, the usage in this document controls.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “about” and“approximately” are used to refer to an amount that is nearly, almost,or in the vicinity of being equal to a stated amount. In this document,the terms “proximal” and “distal” are used to refer to a devicecomponent location relative to a caregiver user. For example, a proximaldevice location would be a location closer to the user of the device,whereas a distal portion location would be a location farther away fromthe user of the device, such as the device portions interacting with asubject recipient. In this document, the term “subject” is meant toinclude mammals, such as for human applications and veterinaryapplications. In this document, the phrases “structured to accommodatenatural anatomical sinus cavity geometry,” “structured to accommodatemaxillary sinus geometry,” or similar mean that the catheter and probehave dimensions (e.g., lengths and cross-sectional sizes) andconfigurations structured to accommodate anatomical geometry associatedwith the nasal passageway and sinus regions.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Also, in the following claims, the terms “including” and“comprising” are open-ended, that is, a system, assembly, apparatus,article, or process that includes elements in addition to those listedafter such a term in a claim are still deemed to fall within the scopeof that claim. Moreover, in the following claims, the terms “first,”“second,” and “third,” etc. are used merely as labels, and are notintended to impose numerical requirements on their objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or morefeatures thereof) can be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. Also, in the above DetailedDescription, various features can be grouped together to streamline thedisclosure. This should not be interpreted as intending that anunclaimed disclosed feature is essential to any claim. Rather, inventivesubject matter can lie in less than all features of a particulardisclosed embodiment. For instance, the treatment and placement devices,methods and kits disclosed herein can provide techniques for treatmentof a frontal sinus, ethmoid sinus, or sphenoid sinus, in addition to amaxillary sinus. In one such example, the device can be structured andconfigured to access the frontal sinus ostium by orienting a terminalportion of the probe upward, and likewise be structured to accommodatethe natural anatomical geometry within the sinus for the frontal sinus.Thus, the following claims are hereby incorporated into the DetailedDescription, with each claim standing on its own as a separateembodiment. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow thereader to quickly ascertain the nature of the technical disclosure. Itis submitted with the understanding that it will not be used tointerpret or limit the scope or meaning of the claims.

1.-10. (canceled)
 11. A method comprising: advancing a catheter and aprobe, the probe including a double-backed portion nested inside thecatheter, within a middle meatus between an intermediate concha and aninferior concha; and accessing a maxillary sinus ostium using thedouble-backed portion of the probe, including actuating a probe tip in apostier to anterior direction.
 12. The method of claim 11, whereinactuating the probe tip and accessing the maxillary sinus ostiumincludes using an uncinate process to aid in guiding the probe tip intothe maxillary sinus ostium.
 13. The method of claim 11, whereinactuating the probe tip includes linearly moving an actuation mechanism,coupled to the probe, in a proximal direction.
 14. The method of claim11, wherein actuating the probe tip includes moving the catheter in ananterior to postier direction.
 15. The method of claim 11, whereinactuating the probe tip includes allowing a preformed probe tip to biasaway from a longitudinal axis of the catheter.
 16. The method of claim11, wherein advancing the catheter and probe, the probe nested insidethe catheter, includes advancing a sinus ostium patency device removablycoupled to a portion of the catheter or probe.
 17. The method of claim11, further comprising performing one or more of: aspiring, dilating,insufflating, draining, delivering fluid medicaments to, or placing apatency device within the maxillary sinus ostium or maxillary sinuscavity.
 18. The method of claim 17, wherein aspiring, dilating,insufflating, draining or delivering fluid medicaments to the maxillarysinus ostium or maxillary sinus cavity includes using one or moreopenings at or near the probe tip and a fluid container in communicationwith a probe proximal end.
 19. The method of claim 17, wherein dilatingthe maxillary sinus ostium includes inflating a balloon coupled to theprobe at or near the probe tip.
 20. The method of claim 19, furthercomprising placing the patency device within the dilated maxillary sinusostium.
 21. The method of claim 11, wherein accessing the maxillarysinus ostium using the probe includes using tactile feedback. 22.-23.(canceled)